Phase 2
Completed N=110
A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).
Source: ClinicalTrials.gov NCT00768079 ↗Enrolled (actual)
110
Serious AEs
25.5%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Participants With Asthma Exacerbations at Week 12 — 38.9; 25.0; 41.7; 38.9 percentage of participants — p=0.312
Summary
The study will evaluate the effect of two intravenous dose regimens of benralizumab (MEDI-563) on the proportion of adult subjects with asthma exacerbations who required an urgent healthcare visit for treatment of an acute asthma exacerbation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Asthma Exacerbations at Week 12 |
38.9; 25.0; 41.7; 38.9; 25.0; 41.7 | 0.312 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
30; 32; 30; 9; 8; 11 | — |
| SECONDARY Percentage of Participants With Asthma Exacerbations at Week 4 and Week 24 |
22.2; 11.1; 22.2; 22.2; 11.1; 22.2 | 0.343 |
| SECONDARY Asthma Control Questionnaire (ACQ) Scores |
3.69; 3.72; 3.26; 1.89; 1.89; 1.52 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites |
1.696; 1.689; 2.067; 2.008; 2.003; 2.254 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Recorded at Home |
1.6346; 1.7119; 1.8404; 1.7800; 1.8562; 1.7674 | — |
| SECONDARY Peak Expiratory Flow (PEF) Recorded at Home |
161.845; 179.000; 177.929; 175.093; 186.538; 172.811 | — |
| SECONDARY Number of Puffs of Rescue Beta-2 Agonist Per Week |
1.95; 1.74; 1.47; 1.80; 1.63; 1.38 | — |
| SECONDARY Number of Participants With Physician Global Assessment (PGA) at Day 42 and Day 84 |
9; 10; 10; 12; 19; 16 | — |
| SECONDARY Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores |
3.14; 3.18; 3.35; 4.74; 4.76; 5.16 | — |
| SECONDARY Number of Healthcare Resources Utilized by Resource Type |
64; 40; 43; 2; 0; 0 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) for Benralizumab |
7.03; 26.7 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) for Benralizumab |
65.7; 263 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUC [0 - Infinity]) for Benralizumab |
67.1; 268 | — |
| SECONDARY Systemic Clearance (CL) for Benralizumab |
4.92; 3.97 | — |
| SECONDARY Terminal Phase Elimination Half-Life (t1/2) for Benralizumab |
11.5; 13.2 | — |
| SECONDARY Volume of Distribution of the Central Compartment (Vc) for Benralizumab |
46.4; 39.8 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) for Benralizumab |
71.8; 64.0 | — |
| SECONDARY Number of Participants With Anti-Drug Antibodies to Benralizumab |
1; 0; 2; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects aged 18 to 60 years at the time of the administration of investigational product
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the US only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
- Physician-diagnosed asthma with a duration of greater than or equal to (>=) 2 years by medical chart or subject report
- Had an asthma exacerbation requiring urgent care in the year prior to screening
- Meets National Heart, Lung, and Blood Institute (NHLBI) for persistent asthma in the 3 months prior to the current urgent healthcare visit
- Current asthma exacerbation that must have lasted >= 2 hours prior to arrival to the urgent healthcare setting
- Requires at least 2 treatments of inhaled bronchodilators for the current asthma exacerbation in the urgent healthcare setting or within the emergency medical system (EMS) for >= 1 hour
- Shows an FEV1 or PEF of not more than 70 percent (%) predicted after 1 hour of treatment of the current asthma exacerbation
- Women of child-bearing potential, unless surgically sterile (including tubal ligation) and/or at least 2 years post-menopausal, must have used 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner, or sterile sexual partner) from screening through the end of the study (Day 84; Cessation of birth control after this point should be discussed with a responsible physician)
- Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Day 0 through Day 84
- Otherwise healthy by medical history and physical examination
- A chest x-ray that is normal for an asthmatic population and excludes alternative diagnosis per the investigation
- Ability to complete the follow-up period until Day 168 as required by protocol
- The investigator has determined that the subject is clinically stable and the FEV1, is >= 30% predicted prior to receiving investigational product on Day 0.
Exclusion Criteria
- Known history of allergy or reaction to any component of the investigational product formulation
- Acute illness other than asthma at the start of the study
- Fever more than (>) 38.6 degrees Celsius (C) (>101.5 degrees Fahrenheit [F])
- Current acute asthma attack is due to aspirin-induced asthma
- Current asthma episode is an anaphylactoid/anaphylactic reaction presenting with acute bronchospasm
- Evidence of clinically significant non-respiratory active infection, including ongoing chronic infection
- History or current prolonged diarrhea, abdominal pain, and/or blood and mucus in stools or have minor symptoms and have exposure to stream or lake water, been exposed to someone who has a parasitic infection (like a family member), or study subject has traveled outside the United States of America (USA) and/or Canada within the last year
- Use of immunosuppressive medication (except oral prednisone and inhaled and topical corticosteroids) within 30 days before randomization into the study
- Have received Xolair within 6 months before randomization into the study
- Receipt of immunoglobulin or blood products within 30 days before randomization into the study
- Receipt of any investigational drug therapy within 6 months before the first dose of investigational product in this study through Day 168
- History of primary immunodeficiency
- Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study
- History of clinically significant abnormality on ECG in the opinion of the investigator
- Pregnancy (must have a negative
Data sourced from ClinicalTrials.gov (NCT00768079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.